Efficacy and Mechanism of Transcranial Temporal Interference Stimulation (tTIS) for Patients With Obsessive-Compulsive Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing HuiLongGuan Hospital

About this trial

Targeted temporal interference stimulation (tTIS) of the nucleus accumbens (NAc) may modulate the abnormal electrophysiological activity in individuals with obsessive-compulsive disorder (OCD), thereby improving their obsessive-compulsive symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Were between 18 and 65 years old;

Were diagnosed with OCD by an experienced psychiatrist utilizing the Structured Clinical Interview for DSM-5 (SCID);

Were able to participate in the entire trial and face-to-face on-site assessment

Disqualifiers

Pregnant or breastfeeding;

Suffered from organic brain diseases or severe physical illness;

Had a history of substance or alcohol abuse;

Presence of comorbid psychiatric disorders (e.g., major depressive disorder) or a high risk of suicide;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Temporal Interference Stimulation

    Device

    Transcranial temporal interference stimulation (tTIS) is a novel neurostimulation technique that utilizes two or more electric fields of specific frequencies to modulate the oscillations of neurons at the desired spatial location in the brain. The physics of tTIS offers the advantage of noninvasively regulating deep brain structures and minimally stimulating the overlying cortex outside the selected target.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Nucleus accumbens group (tTIS)Experimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Obsessive-compulsive symptoms

Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The Y-BOCS total score ranges from 0 to 40, with higher scores indicating greater symptom severity.

Time frame
Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up

Secondary outcomes

1

Self-reported obsessive-compulsive symptoms

The reduction rate of the score of Obsessive-Compulsive Inventory-Revised (OCI-R), a self-rating scale of OCD symptoms severity, was employed as a secondary outcome.

Time frame
Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
2

Multimodal MRI measures

Multimodal MRI data will be acquired at baseline and after completion of the 5-day intervention using a 3.0-T MRI scanner. The imaging protocol includes T1-weighted and T2-weighted structural MRI, resting-state blood-oxygen-level-dependent (BOLD) functional MRI, and diffusion-weighted imaging (DWI).

Time frame
Baseline, after completion of 5-day intervention
3

Resting-state electroencephalography (EEG) measures

Resting-state EEG will be recorded at baseline and after completion of the 5-day intervention. Changes in EEG-derived neurophysiological measures between baseline and post-intervention will be assessed to characterize intervention-related alterations in brain activity.

Time frame
Baseline, after completion of 5-day intervention
4

Behavioral task performance

Behavioral task performance will be assessed at baseline and after the 5-day intervention using computerized cognitive tasks. Task-derived behavioral measures, such as instrumental learning tasks and probabilistic reversal learning tasks, will be analyzed to evaluate intervention-related changes in behavioral performance.

Time frame
Baseline, after completion of the 5-day intervention

Other outcomes

Sponsors and contacts

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Beijing HuiLongGuan Hospital

Lead sponsor

Tsinghua University

Collaborator

The First People's Hospital of Hefei

Collaborator